First Major Drug Recall of 2011

For decades, McNeil Consumer Healthcare has given the world some of the most popular over-the-counter (OTC) medications, including Tylenol, Motrin, Benadryl, Sudafed, and Zyrtec. But with a long string of recent product recalls, McNeil  is at risk of losing consumer trust.

The latest recall affects several highly popular brands. In consultation with the U.S. Food and Drug Administration (FDA), McNeil has announced its recall of certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

The company says that the recall is a precautionary measure  taken after an extensive review of past production records found instances where equipment cleaning procedures were insufficient, or where cleaning was not adequately documented. The company believes that it is very unlikely that this impacted the quality of these products, but the products are being recalled out of an abundance of caution.

The recall affects wholesale only:

No action is required by consumers or healthcare providers and consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events. [from the FDA recall press release]

An article in the Baltimore Sun reports that:

Johnson & Johnson, which owns McNeil Consumer Healthcare, has come under scrutiny in the past year because it has recalled about 288 million items, including about 136 million bottles of liquid Tylenol, Motrin, Zyrtec and Benadryl for infants and children.

The problems stem from quality-control issues in multiple factories. Last year’s recalls were sparked because some of its consumer products contained bits of metal, while others came in bottles with a moldy smell.

Consumers can access full product details and other information about the recall on the website, or by calling the company’s Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

Although McNeil says that consumers won’t have their health affected by their products, we always advise clients to report any unusual symptoms or drug side effects to their physician or health care provider. For more information about how drugs can affect your health, visit our drug toxicity web page here: HensonFuerst Drug Injury page.

If you have questions, HensonFuerst has answers.

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